When depression disturbs sleep …

A newcomer against depression, agomelatine has just been granted a marketing authorization in Europe and should soon be able to be prescribed in the United States. Leader of a new therapeutic class, it brings a real hope in the treatment of this disease.

Valdoxan: a new mode of action

In October 2012, the ANSM drug agency warned against the risk of potentially serious liver damage associated with taking the antidepressant Valdoxan

Who should use agomelatine?

A new antidepressant, agomelatine, was granted marketing authorization in early 2009 by the European Medicines Agency (EMEA). Marketed by Servier Laboratories under the name of Valdoxan, agomelatine has a unique mode of action: it regulates the internal clock, disturbed by depression, by imitating melatonin, our "sleep hormone."

The origin of this new antidepressant is a simple observation: in case of depression, the biological clock is disturbed. In other words, the sleep-wake cycle, also called circadian rhythm, is "desynchronized". Thus, the majority of people treated for depression have sleep disorders, including difficulty falling asleep, frequent awakening, early morning awakening ... With sometimes serious consequences, as insomnia is a major risk factor Of suicide in depressed people.

Now it is a hormone, melatonin, which naturally regulates our circadian rhythm. Produced overnight in response to darkness, melatonin triggers falling asleep and ensures restful sleep. Its peak of secretion is maximal around 3 o'clock in the morning. But in the case of depression, the synthesis of melatonin is out of phase and the peak is very small or even non-existent. Hence the idea of ​​correcting this deficit to cure depressive disorders ...

Agomelatine is the first antidepressant regulating the circadian cycle. It mimics the action of melatonin while acting on serotonin, which is the "classic" target of most antidepressants.

And the formula works: Clinical trials, conducted in 4,000 patients, showed an efficacy of agomelatine on the symptoms of depression, including sadness and anxiety, but also on sleep disorders. They diminish in the first week and do not generally reappear when treatment is discontinued. A real plus when we know that these disorders, which often persist with classic antidepressants, are a factor in the recurrence of depression.

In practice, agomelatine can be delivered on prescription to people suffering from a major depressive episode. It is particularly effective on bipolar disorders and seasonal depression, due to lack of light and therefore to a dysregulation of melatonin.

Valdoxan is in the form of tablets containing 25 mg of agomelatine, to be taken at bedtime. The most common side effects are headaches, "cold" symptoms and gastrointestinal disorders, which are comparable in intensity to the effects of other antidepressants. However, agomelatine does not appear to cause a decrease in libido, often found in conventional antidepressant therapy, and is not accompanied by weight gain.

By its innovative mode of action, agomelatine is therefore a hope for the 30% of depressed patients who do not respond to other available antidepressants.

Committee on Medicinal Products for Human Use Summary of Positive Opinion for Valdoxan (emea); Haffen - Besançon, From rhythms to clinical expressions: A novel mechanism of antidepressant action involving the melatonergic and the serotonergic system